DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 May 2025 has been entered.
This Office Action is responsive to the amendment filed on 16 May 2025. As directed by the amendment: claims 1 and 19-20 have been amended, claim 5 has been canceled, and no claims have been added. Thus, claims 1-4 and 6-20 are presently pending in this application.
Response to Arguments
I. 35 USC § 101 Rejections:
Applicant's arguments filed 16 May 2025 have been fully considered but they are not persuasive.
Step (a): Providing therapeutic stimulation:
Applicant argues that “the Examiner is incorrect in concluding that therapeutic stimulation ‘amounts to no more than mere pre-solution activity’ to measuring neural responses” because “providing therapeutic stimulation is clearly more than just presolution activity; it is not merely a pre-cursor for measuring the neural responses” (Remarks, page 8). Examiner respectfully disagrees. MPEP 2106.04(d)(2) states:
A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter.
…
c. Whether The Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use
The treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. For example, consider a claim that recites (a) administering rabies and feline leukemia vaccines to a first group of domestic cats in accordance with different vaccination schedules, and (b) analyzing information about the vaccination schedules and whether the cats later developed chronic immune-mediated disorders to determine a lowest-risk vaccination schedule. Step (b) falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. Conversely, consider a claim reciting the same steps (a) and (b), but also reciting step (c) "vaccinating a second group of domestic cats in accordance with the lowest-risk vaccination schedule." Step (c) applies the exception, in that the information from the mental analysis in step (b) is used to alter the order and timing of the vaccinations so that the second group of cats has a lower risk of developing chronic immune-mediated disorders. Step (c) thus integrates the abstract idea into a practical application.
In claim 1, the judicial exceptions are “determining a value for the neural response” and “determining one or more first thresholds for the therapeutic stimulation using the determined value for the neural response”, which are analogous to step (b) described in the example cited above, as these are mental processes. Similar to step (a) of the example above, the step of “providing the therapeutic stimulation to a spinal cord of the patient … to treat the patient’s back pain” as recited in claim 1 is performed in order to “measure … a neural response to the therapeutic stimulation”, which is analogous to gathering data for the mental analysis steps of “determining a value for the neural response” and “determining one or more first thresholds for the therapeutic stimulation using the determined value for the neural response”. Therefore, the step of providing therapeutic stimulation is extra-solution activity, and does not integrate the judicial exception into a practical application.
Step (b): Measuring neural responses:
Applicant argues that “Examiner is incorrect in concluding that measuring neural responses is only a precursor to determining thresholds” because “Applicant's specification well explains that a neurostimulation device can measure neural responses for the useful purpose of adjusting stimulation that the neurostimulator is providing, even without determining any thresholds” (Remarks, page 9). Examiner respectfully disagrees. There is no indication in claims 1, 19, and 20 that the stimulation parameters are adjusted as a result of measuring the neural response. Therefore, the steps of measuring neural responses, determining a value, and determining one or more first thresholds are not integrated into a practical application.
Judging claim as a whole:
Applicant argues that the “claims recite nonabstract limitations, and as such, on the whole, are not objectionable on § 101” because “Applicant's claimed steps (a) and (b) are clearly not Abstract” (Remarks, page 9). Examiner respectfully disagrees. As explained above, the steps of providing therapeutic stimulation and measuring neural responses are not integrated into a practical application because these steps are necessary precursors for the steps of determining a value and determining one or more first thresholds. Therefore, claims 1, 19, and 20 as a whole do not integrate the abstract ideas into a practical application, and are patent-ineligible under 35 U.S.C. 101.
II. Rejections Over the Prior Art:
Applicant’s arguments, see Remarks, filed 16 May 2025, with respect to the rejections of claims 1 and 19-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Esteller et al. (US 20190209844 A1, previously cited), hereinafter Esteller, under 35 U.S.C. 102, as explained in further detail below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claim 1 recites a process (method), claim 19 recites a machine (system), and claim 20 recites a manufacture (non-transitory computer-readable medium), which are within the four statutory categories. Therefore, claims 1, 19, and 20 are directed to a statutory category of invention.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 19, and 20 are directed to an abstract idea.
Claim 1 is directed to (a) providing the therapeutic stimulation to the patient via the implantable neurostimulator, wherein the therapeutic stimulation comprises a plurality of stimulation parameters; (b) measuring at the implantable neurostimulation a neural response to the therapeutic stimulation and determining a value for the neural response, wherein the neural response comprises an Evoked Compound Action Potential; and (c) determining one or more first thresholds for the therapeutic stimulation using the determined value for the neural response, wherein each first threshold is determined using a first mathematical relationship that models each first threshold as a function of values of the neural response.
Claims 19 and 20 also recite these limitations as part of the functions of an external device (in claim 19) and as part of instructions for an external device (in claim 20).
The limitations of “determining a value for a neural response” and “determining one or more first thresholds using the determined value for the neural response”, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are akin to having a doctor or other human actor performing these operations with pen and paper. For example, “determining a value for a neural response” encompasses nothing more than a human actor mentally evaluating collected data. “Determining one or more first thresholds for the therapeutic stimulation using the determined value for the neural response, wherein each first threshold is determined using a first mathematical relationship that models each first threshold as a function of values of the neural response” encompasses nothing more than a human actor using pen and paper to perform calculations using the determined value for the neural response.
Therefore, claims 1 and 19-20 recite an abstract idea.
Claims 2-4 and 6-18 depend on claim 1. These dependent claims only recite additional features of the analysis described in claim 1, which may also be performed by a human actor mentally and using a pen and paper. For example, claim 2 recites “wherein the one or more first thresholds comprise thresholds for one of the stimulation parameters that causes a physiological response in the patient, wherein the physiological response comprises one or more of paresthesia and discomfort”, which encompasses nothing more than a human actor finding thresholds of paresthesia and discomfort empirically through trial and error.
Therefore, claims 1-4 and 6-20 recite an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application.
Claims 19 and 20 recite the additional limitation “an external device”. This additional element is recited at a high level of generality (i.e. most generic computers would be known to have these components). Paragraphs [0016]-[0017] describe the external device as a clinician programmer 70 or external controller 60, which have control circuitry 88 and 66, respectively. These generic control circuitry limitations are no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore claims 19 and 20 do not integrate the judicial exception into a practical application.
Claims 1 and 19-20 recite the additional limitation “(a) providing the therapeutic stimulation to the patient via the implantable neurostimulator, wherein the therapeutic stimulation comprises a plurality of stimulation parameters” in order to “determine a value for a neural response, wherein the neural response is formed in response to the therapeutic stimulation”, which amounts to no more than mere pre-solution activity of data gathering. It is noted that these steps are performed prior to the analysis/determination steps, and therefore are considered pre-solution activity. Therefore the claimed generic implantable neurostimulator element does not integrate the judicial exception into a practical application.
Thus, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea. As described above, dependent claims 2-18 only recite other limitations of determining a value for a neural response and of determining one or more first thresholds for the therapeutic stimulation, which may be done mentally by a human actor and/or with a pen and paper.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As explained above with respect to the integration of the judicial exception into a practical application (Step 2A, Prong 2), the additional elements of using computer components to perform the process steps amounts to no more than mere instructions to apply the judicial exception using generic computer elements. The structural element recited in claims 19 and 20 is “an external device” with “control circuitry”. These additional elements are recited at a high level of generality (i.e. most generic computers would be known to have these components). Paragraphs [0016]-[0017] of the specification describes the processor and non-transitory computer-readable medium at a high level of generality, and only provides conventional, well-known computing functions that do not add meaningful limits to practicing the abstract idea.
Claims 1 and 19-20 recite the additional limitation “an implantable neurostimulator”. As discussed above with respect to integration of the abstract idea into a practical application (Step 2A, Prong 2), the additional element of an implantable neurostimulator to collect data amounts to no more than mere pre-solution activity of data gathering. It is noted that these steps are performed prior to the analysis/determination steps, and therefore are considered pre-solution activity. This pre-solution activity of data gathering using a catheter is well-understood, routine, and conventional in the field of neurostimulation technology. For example, see US Publication No. 20170296823 A1 (Figs. 8-9, paragraphs [0044]-[0056]), which describes known methods of sensing evoked compound action potentials. Therefore, the claimed generic implantable neurostimulator and computer processing elements are all well-understood, routine, and conventional in the first of neurostimulation technology.
Therefore, claims 1-4 and 6-20 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
It is noted that amending claims 1, and 19-20 with limitations regarding “controlling patient stimulation therapy” as recited in the specification (paragraphs [0056]; [0065], “The controller 60 can automatically periodically run either of algorithms 150 or 180 to measure ENTs (possibly at different pulse widths), and to adjust physiological thresholds accordingly, which in turn affects the patient's stimulation.”) would add a specific practical application of the claimed analysis, and could potentially overcome ineligibility issues under 35 USC 101 by adding explicit treatment therapy. All amendments must have full support in the instant specification and/or drawings as originally filed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Esteller et al. (US 20190209844 A1, previously cited), hereinafter Esteller.
Regarding claim 1, Esteller discloses a method for determining one or more first thresholds for therapeutic stimulation provided to a patient (Fig. 12, paragraph [0078], calibration mode 1102) by an implantable neurostimulator (paragraph [0077], IPG 100), comprising:
(a) providing the therapeutic stimulation to a spinal cord of the patient via the implantable neurostimulator (paragraph [0079], "Stimulation can be delivered at preset settings with an initial, minimal amplitude") to treat the patient's back pain (paragraph [0039], "Some SCS embodiments deliver sub-perception therapy that is therapeutically effective to treat pain"), wherein the therapeutic stimulation comprises a plurality of stimulation parameters (paragraph [0079], amplitude, preset settings);
(b) measuring at the implantable neurostimulator a neural response to the therapeutic stimulation (paragraph [0079], "he amplitude is progressively increased until the user can detect ECAPS at one or more of the available channels") and determining a value for the neural response (paragraph [0084], ECAP visual threshold, extracted ECAP threshold; paragraph [0085]), wherein the neural response comprises an Evoked Compound Action Potential (paragraph [0079], "detect ECAPS at one or more of the available channels"); and
(c) determining one or more first thresholds for the therapeutic stimulation using the determined value for the neural response (paragraph [0084], "Other thresholds (such as perception, discomfort, or others) can also automatically be determined, by establishing the relation between those other thresholds and the ECAP threshold during the calibration mode. For example, from the calibration mode, the perception threshold and the ECAP threshold (visual ECAP threshold or extracted ECAP threshold) are determined for specific stimulation settings and/or posture, therefore, the system can determine their relation and measure the ECAP threshold for different settings and/or posture and assess the perception threshold from the measured ECAP threshold."), wherein each first threshold is determined using a first mathematical relationship that models each first threshold as a function of values of the neural response (paragraph [0084], "establishing the relation between those other thresholds and the ECAP threshold"; paragraph [0087], "PT may be estimated based on the ECAP threshold PhT").
Regarding claim 2, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that the one or more first thresholds comprise thresholds for one of the stimulation parameters that causes a physiological response in the patient, wherein the physiological response comprises one or more of paresthesia (paragraph [0087], "Another relevant threshold stimulation value is the perception threshold (PT), which is the minimum stimulation intensity at which the patient perceives the stimulation, typically as paresthesia") and discomfort (paragraph [0085], "discomfort threshold, which corresponds to the minimum stimulation intensity that causes discomfort for the patient").
Regarding claim 3, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that the one or more first thresholds comprise physiological thresholds, wherein the one or more physiological thresholds comprise one or more of a perception threshold (paragraph [0087], "Another relevant threshold stimulation value is the perception threshold (PT)") and a discomfort threshold (paragraph [0085], "discomfort threshold, which corresponds to the minimum stimulation intensity that causes discomfort for the patient").
Regarding claim 4, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that the one or more first thresholds comprise thresholds for an amplitude of the therapeutic stimulation (paragraph [0085], "intensity" is analogous to "amplitude"; paragraph [0087], "PT may be estimated based on the ECAP threshold PhT"; paragraph [0086], "PhT may be taken as the minimum stimulation amplitude that results in a visible ECAP signal without ECAP extraction processing").
Regarding claim 6, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that the value for the neural response comprises a value of one of the stimulation parameters, wherein the value for the neural response comprises a minimum value of the one of the stimulation parameters at which the neural response is detectable (paragraph [0086], "PhT may be taken as the minimum stimulation amplitude that results in a visible ECAP signal without ECAP extraction processing").
Regarding claim 7, Esteller discloses the method of claim 6, as explained above. Esteller further discloses that the one of the stimulation parameters comprises an amplitude of the therapeutic stimulation (paragraph [0086], "PhT may be taken as the minimum stimulation amplitude that results in a visible ECAP signal without ECAP extraction processing").
Regarding claim 8, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that the first mathematical relationship that models each first threshold is a linear function of the values of the neural response (paragraph [0087], PT=C×PhT is a linear equation).
Regarding claim 9, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that the value for the neural response comprises an extracted neural threshold (paragraph [0080], "Signal processing extraction techniques may be used to extract ECAP responses"; Fig. 13, paragraphs [0081]-[0083]; paragraph [0084], "ECAP is detected on a selected channel, with or without the use of ECAP extraction processing").
Regarding claim 10, Esteller discloses the method of claim 1, as explained above. Esteller further discloses that an external device communicates with the implantable neurostimulator (paragraph [0077], "The calibration mode 1102 will typically be executed during the fitting process with the aid of the clinician programmer 90 or an allowed 'patient programmer' (given clinician permission) with specific programming features, though aspects of the calibration mode may be executed using the external controller 50"; paragraph [0078], "although a clinician typically performs the calibration mode 1102 during the fitting procedure using the clinician programmer 90, the patient may also perform aspects of the calibration mode using the external controller 50 or a software application in smart device").
Regarding claim 11, Esteller discloses the method of claim 10, as explained above. Esteller further discloses that the value for the neural response is determined in the external device (paragraph [0084], "Once an ECAP is stored for a selected channel, the ECAP visual threshold can be automatically determined by the system, and also the extracted ECAP threshold").
Regarding claim 12, Esteller discloses the method of claim 10, as explained above. Esteller further discloses that the method is initiated at a user interface of the external device (paragraph [0078], "The user, typically a clinician, is presented with a user interface, such as a graphical user interface (GUI)").
Regarding claim 13, Esteller discloses the method of claim 10, as explained above. Esteller further discloses that the first mathematical relationship for each of the first thresholds is stored in the external device (paragraph [0089], "stores the extracted ECAPs and their metrics").
Regarding claim 14, Esteller discloses the method of claim 13, as explained above. Esteller further discloses that the one or more first thresholds is determined in the external device (paragraph [0084], "the ECAP visual threshold can be automatically determined by the system, and also the extracted ECAP threshold").
Regarding claim 15, Esteller discloses the method of claim 1, as explained above. Esteller further discloses providing test stimulation to the patient via the implantable neurostimulator, wherein the test stimulation is provided at a plurality of different test pulse widths (paragraph [0062]).
Regarding claim 16, Esteller discloses the method of claim 15, as explained above. Esteller further discloses determining values for a neural response at each of the test pulse widths, wherein the neural response is formed in response to the test stimulation (paragraph [0089], "calibration mode 1102 progressively varies one stimulation parameter such as intensity, pulse width, frequency, cycling, pulse shape, stimulating electrode, or other, and it stores the extracted ECAPs and their metrics for the different postures. The ECAPs metrics are related to the stimulation parameter varied at each specific position or body activity.")
Regarding claim 17, Esteller discloses the method of claim 16, as explained above. Esteller further discloses determining a second mathematical relationship that models values for the neural response as a function of pulse width using the values for the neural response as determined at each of the test pulse widths (paragraph [0089], "The calibration mode 1102 derives the relation between the stimulation parameter and the ECAP metric for each posture or body activity").
Regarding claim 18, Esteller discloses the method of claim 17, as explained above. Esteller further discloses that in step (a) the therapeutic stimulation is provided to the patient at a therapeutic pulse width (paragraph [0089], "calibration mode 1102 progressively varies one stimulation parameter such as ... pulse width"), and that in step (b) the value for the neural response is determined using the second mathematical relationship determined at the therapeutic pulse width (paragraph [0089], "The calibration mode 1102 derives the relation between the stimulation parameter and the ECAP metric for each posture or body activity").
Regarding claim 19, Esteller discloses a system, comprising:
an external device configured to communicate with an implantable neurostimulator (paragraph [0077], "The calibration mode 1102 will typically be executed during the fitting process with the aid of the clinician programmer 90 or an allowed 'patient programmer' (given clinician permission) with specific programming features, though aspects of the calibration mode may be executed using the external controller 50"; paragraph [0078], "although a clinician typically performs the calibration mode 1102 during the fitting procedure using the clinician programmer 90, the patient may also perform aspects of the calibration mode using the external controller 50 or a software application in smart device"), wherein the external device is configured to:
(a) program the implantable neurostimulator to provide the therapeutic stimulation to a spinal cord of the patient via the implantable neurostimulator (paragraph [0079], "Stimulation can be delivered at preset settings with an initial, minimal amplitude") to treat the patient's back pain (paragraph [0039], "Some SCS embodiments deliver sub-perception therapy that is therapeutically effective to treat pain"), wherein the therapeutic stimulation comprises a plurality of stimulation parameters (paragraph [0079], amplitude, preset settings);
(b) cause the implantable neurostimulator to measure a neural response to the therapeutic stimulation (paragraph [0079], "The amplitude is progressively increased until the user can detect ECAPS at one or more of the available channels") and determine a value for the neural response (paragraph [0084], ECAP visual threshold, extracted ECAP threshold; paragraph [0085]), wherein the neural response comprises an Evoked Compound Action Potential (paragraph [0079], "detect ECAPS at one or more of the available channels"); and
(c) determine one or more first thresholds for the therapeutic stimulation using the determined value for the neural response (paragraph [0084], "Other thresholds (such as perception, discomfort, or others) can also automatically be determined, by establishing the relation between those other thresholds and the ECAP threshold during the calibration mode. For example, from the calibration mode, the perception threshold and the ECAP threshold (visual ECAP threshold or extracted ECAP threshold) are determined for specific stimulation settings and/or posture, therefore, the system can determine their relation and measure the ECAP threshold for different settings and/or posture and assess the perception threshold from the measured ECAP threshold."), wherein each first threshold is determined using a first mathematical relationship that models each first threshold as a function of values of the neural response (paragraph [0084], "establishing the relation between those other thresholds and the ECAP threshold"; paragraph [0087], "PT may be estimated based on the ECAP threshold PhT").
Regarding claim 20, Esteller discloses a non-transitory computer readable medium comprising instructions executable on an external device to communicate with an implantable neurostimulator (paragraph [0076]), wherein the instructions are configured to:
(a) render a user interface on the external device to allow a user to program the implantable neurostimulator to provide therapeutic stimulation to a spinal cord of the patient via the implantable neurostimulator (paragraph [0079], "Stimulation can be delivered at preset settings with an initial, minimal amplitude") to treat the patient's back pain (paragraph [0039], "Some SCS embodiments deliver sub-perception therapy that is therapeutically effective to treat pain"), wherein the therapeutic stimulation comprises a plurality of stimulation parameters (paragraph [0079], amplitude, preset settings);
(b) cause the implantable neurostimulator to measure a neural response to the therapeutic stimulation (paragraph [0079], "he amplitude is progressively increased until the user can detect ECAPS at one or more of the available channels") and determine a value for the neural response (paragraph [0084], ECAP visual threshold, extracted ECAP threshold; paragraph [0085]), wherein the neural response comprises an Evoked Compound Action Potential (paragraph [0079], "detect ECAPS at one or more of the available channels"); and
(c) determine one or more first thresholds for the therapeutic stimulation using the determined value for the neural response (paragraph [0084], "Other thresholds (such as perception, discomfort, or others) can also automatically be determined, by establishing the relation between those other thresholds and the ECAP threshold during the calibration mode. For example, from the calibration mode, the perception threshold and the ECAP threshold (visual ECAP threshold or extracted ECAP threshold) are determined for specific stimulation settings and/or posture, therefore, the system can determine their relation and measure the ECAP threshold for different settings and/or posture and assess the perception threshold from the measured ECAP threshold."), wherein each first threshold is determined using a first mathematical relationship that models each first threshold as a function of values of the neural response (paragraph [0084], "establishing the relation between those other thresholds and the ECAP threshold"; paragraph [0087], "PT may be estimated based on the ECAP threshold PhT").
Conclusion
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/CHRISTINE SISON/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796